Job Description

Main Duties:

To include, but not be restricted to, the following duties:

To have specific responsibility for defining and implementing a compliant, robust system for all types and levels of Change Management and Validation across the networked Group of laboratories and operations.

To have specific responsibility for supporting a compliant approach to technically based changes across the network, including equipment, laboratory based, general structural and IT (Laboratory Information Systems).

To act as sponsor and lead for complex changes and validations that require technical input to ensure seamless transmission.

To assist in general Quality Management duties, including, but not limited to:

Maintaining the Quality Policy for the laboratories as directed.

Maintaining the Quality Management System within the laboratories

To assist with the establishment and documentation of quality objectives, including formulating a plan for achieving these objectives

To assist in the preparation, administration, dissemination and regular review of quality manuals for the laboratories.

To ensure that the quality management system functions correctly by managing and maintaining quality monitoring systems

To assist in maintaining the document control system for the laboratories

To assist in maintaining the system for control of technical records for the laboratories

To participate in the management review procedure for the quality management system

To participate in the ongoing evaluation and improvement processes for the laboratories

To engage in activities for measuring system performance of the laboratories

To engage in activities for measuring process performance of the laboratories

To assist in maintaining systems to facilitate the continuing improvement in laboratory services

To ensure all quality procedures are performed in accordance with the relevant Health and Safety policy and procedures.

General Duties

To become familiar with the day - to day organisation of the department as it affects your work. You should be aware of the functions of the members of staff in the department as they affect your work. To attend meetings as required.

To undertake such work as you are assigned in a careful and efficient way and in compliance with current CPA / UKAS standards, regulatory requirements and the Quality Management System.

To communicate in a friendly, helpful and non-prejudicial manner in your dealings with staff, clients and / or customers as you will be regarded as a representative of your department as well as the Company, and you should behave accordingly. Matters regarding patients are confidential and must not be discussed except in the course of your duties. You will be expected to sign an undertaking to observe all patient and Company confidentiality.

To be aware of and abide by the rules and codes of the department. This is particularly important in the case of Health and Safety and Fire procedures. To behave in a professional manner and cooperate with all other members of staff at all times.

You will be trained for the work you are expected to do. Do not attempt any work unless you are confident that you can carry it out properly.

To adhere to and to positively promote the Core Values.

To maintain high standards of work within your department.

To travel to locations assigned across the network in order to be able to support the duties outlined.

Other duties as assigned by the Director of Quality and the Principal Quality Manager.

Person Specification

Attributes

Requirements

Qualifications

Good general standard of education, preferably a science degree, or equivalent.

Experience

Experience of working within the healthcare field (preferably experience working in a QA / regulatory environment).

Experience of working with Laboratory Information Systems

Significant experience of Change Management and validation processes

Report writing experience.

Skills and Abilities

Excellent written and verbal communication skills.

Ability to work on own initiative and as part of a team.

Numerate.

Highly skilled in use of Microsoft Office and LIMS.

Experience of utilising statistical analysis software.

Able to take minutes and write reports

Personal Qualities

Flexible, highly motivated, effective team player; methodical, ability to understand and meet targets and deadlines, able to learn and assimilate new information.

Commitment to working the hours required to fulfil the job, including flexibility of working.